Trial | NCT02855788  Report issue

Title

Metronomic Chemotherapy in Advanced Gastric Cancer
Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.
Study Started
May 31
2015
Primary Completion
Jul 31
2018
Anticipated
Study Completion
Oct 31
2018
Anticipated
Last Update
Aug 04
2016
Estimate

Drug Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

metronomic chemotherapy

  • Other names: Taxol, Eloxatin

POLF regimen Experimental

Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly

Criteria 

Inclusion Criteria:

pathologically confirmed gastric cancer AJCC stage III or IV
measurable disease based on CT or endoscopy exam
non-surgical candidates or patients who declined surgery
non-radiation candidates or patients who declined radiation
patients who are able to sign informed consent
patients who are 2 weeks out and recovered from surgery
patients who have completed radiation to relieve obstructive symptoms
patient who previously received Oxaliplatin and 5-FU in other MTD regimens
adequate marrow function: neutrophil >1000/ul, Hgb >10g/dl, Plt>50,000

Exclusion Criteria:

allergic to any of the drugs involved
concurrent malignancies
severe co-morbidities of heart, lungs, kidneys and bone marrow
severe psychological disorder
severe malnutrition
difficult to heal or unhealed wound
ECOG performance status equal or over 3
uncontrolled complications from the malignancy
uncontrolled CNS metastasis
peripheral neuropathy grade 3 or above
pregnancy or breast feeding
No Results Posted